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This study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy.
Condition or disease
The regimen is an attempt to create a middle ground between the 2 commonly used regimens - "single dose" and "multi dose". The "multi dose" regimen is more effective, but the "single dose" regimen is more convenient for patients and has fewer side effects.
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Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Confirmed diagnosis of ectopic pregnancy via
D&E without products of conception identified on frozen pathology or
VABRA without products of conception identified with pathologic evaluation or
Ultrasound visualization of a gestational sac in the adnexa, with definitive visualization of a yolk sac or fetal pole
the subject is hemodynamically stable without signs of hemoperitoneum
laparoscopy has not been performed
the subject is able to return for frequent follow-up care
normal renal and liver function have been documented within 2 days
normal white blood count and platelet count have been documented as per laboratory standard
normal chest x-ray was obtained if the subject has a history of pulmonary disease
no history of allergy or sensitivity to methotrexate or any component of its formulation
laboratory evidence of immunodeficiency
alcoholism or chronic liver disease
the concomitant use of non-steroidal anti-inflammatory drugs
blood dyscrasia such as leukopenia, thrombocytopenia, or severe anemia
active pulmonary disease
hepatic, renal, or hematological dysfunction
adnexal mass > or = 3.5 cm
presence of fetal cardiac motion
active major psychiatric disorder such as major depression, bipolar disease, psychotic disorder, or drug addiction
subjects unable or unwilling to comply with study procedures or illiterate